Kornimate/medical-research-clean huggingface dataset:
a study of the safety and efficacy of gdc-0853 in participants with moderate to severe active systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: this is a study to evaluate the safety and efficacy of gdc-0853 in combination with standard of care therapy in participants with moderate to severe active systemic lupus erythematosus (sle).


Eligibility criteria:
inclusion criteria: * fulfillment of sle classification criteria according to either american college of rheumatology (acr) or systemic lupus international collaborating clinics (slicc) criteria at any time prior to or at screening * at least one serologic marker of sle at screening as follows: positive antinuclear antibody (ana) test by immunofluorescent assay with titer \>/= 1:80; or positive anti-double-stranded dna (anti-dsdna) antibodies; or positive anti-smith antibody * at both screening and day 1, moderate to severe active sle, defined as meeting all of the following unless indicated otherwise: systemic lupus erythematosus disease activity index 2000 (sledai-2k) score ≥ 8 (at screening only) with clinical sledai-2k score \>/= 4.0 (at both screening and day 1), physician's global assessment \>/= 1.0 (out of 3), and currently receiving at least one standard oral treatment for sle * if on oral corticosteroids (ocs), the dose must be \</= 40 mg/day prednisone (or equivalent) * stable doses of anti-malarial or immunosuppressive therapies * participants must be willing to avoid pregnancy exclusion criteria: * proteinuria \> 3.5 g/24 h or equivalent using urine protein-to-creatinine ratio (upcr) in a first morning void urine sample * active proliferative lupus nephritis (as assessed by the investigator) or histological evidence of active class iii or class iv lupus nephritis on renal biopsy performed in the 6 months prior to screening (or during the screening period) * history of having required hemodialysis or high dose corticosteroids (\>100 mg/d) prednisone or equivalent) for the management of lupus renal disease within 90 days of day 1 * neuropsychiatric or central nervous system lupus manifestations * serum creatinine \> 2.5 mg/dl, or estimated glomerular-filtration rate \< 30 milliliter per minute (ml/min) or on chronic renal replacement therapy * history of receiving a solid organ transplant * evidence of active, latent, or inadequately treated infection with mycobacterium tuberculosis (tb) * significant and uncontrolled medical disease within the 12 weeks prior to screening in any organ system (e.g., cardiac, neurologic, pulmonary, renal, hepatic, endocrine, metabolic, gastrointestinal, or psychiatric) not related to sle, which, in the investigator's or sponsor's opinion, would preclude study participation * history of cancer, including hematological malignancy and solid tumors, within 10 years of screening * need for systemic anticoagulation with warfarin, other oral or injectable anticoagulants, or anti-platelet agents * evidence of chronic and/or active hepatitis b or c
applying directly observed therapy to hydroxyurea to realize effectiveness

Conditions: Sickle Cell Disease

Summary: this study is for caregivers of young children with sickle cell disease and adolescents with sickle cell disease who are currently prescribed hydroxyurea and are receiving care at one of the study sites. the study will assess retention and engagement during a pilot randomized control trial comparing video directly observed therapy (vdot) to attention control. we also hope to understand more about patient and family preferences longer-term adherence monitoring and intervention. participants will use an electronic adherence monitor (provided by the study team) to measure how often they are taking their hydroxyurea. participants will also be asked to complete questionnaires throughout the study period to provide information about their expectations for, experience with, and satisfaction with the study materials.

this is an investigator-blinded, multi-center pilot randomized controlled trial (rct) of adolescents with sickle cell disease (scd) and caregivers of young children with scd. after completion of a run-in period, subjects will undergo randomization to either six months of video directly observed therapy (vdot) or attention control. electronic adherence monitors will be used to measure adherence. after the intervention period, all participants will then complete a six-month ongoing monitoring period where vdot participants will continue to use electronic adherence monitors and receive intermittent communication to encourage adherence and attention controls will continue to use their electronic adherence monitors. the investigators are partnering with a small business, scene health, to administer vdot. outcomes such as engagement, retention, and satisfaction will be measured through survey data collected at routine study visits. sickle cell-related outcomes and healthcare utilization will be abstracted from patient electronic medical records throughout each study period. adherence data will be recorded by the electronic adherence devices.

Eligibility criteria:
inclusion: adult caregivers will be eligible if they: * are english speaking. * have a child who is 1-10 years of age with scd (any genotype) who has been prescribed hydroxyurea for at least 180 days prior to enrollment. * note: caregivers who have multiple children meeting criteria will only be able to enroll once. adolescents (\>11 years at enrollment) are eligible if they: * are english speaking. * are 11-25 years of age. * have a diagnosis of scd (any genotype) and have been prescribed hydroxyurea for at least 180 days prior to enrollment. exclusion: * adolescents and caregivers of younger children who participated in the previous vdot study will be excluded. * adolescents and caregivers of younger children receiving multiple scd modifying treatments (e.g., chronic transfusions or l-glutamine) will be excluded. randomization: enrolled subjects will be eligible for randomization if they open their electronic adherence monitoring device at home at least once during the run-in period.

Keywords: sickle cell disease hydroxyurea adherence
comparison of oxford uka and sigma uka with rsa.

Conditions: Knee Osteoarthritis; Knee Replacement; RSA

Summary: comparison of two unicompartmental knee arthroplasties (uka), to see if sigma uka performs equally good as the oxford uka. the study focuses on how well the arthroplasty is fixated to the bone and on the difference in wear of the plastic insert. finally, the functional outcome after surgery is compared between the two arthroplasties. hypothesis: h1: the sigma uka has an equal migration pattern compared to the oxford uka with a follow up of two years - that is, no significant difference in migration between 1-2 years follow-up. h2: the oxford and sigma uka's have comparable polyethylene wear with a follow up of 5 years. h3: the oxford and sigma uka's have comparable patient perceived outcome measures (prom) and leg extension power (lep) postoperative. h4: bmd of the proximal tibia does not influence migration of the tibial component


Eligibility criteria:
inclusion criteria: * all eligable patients with medial osteoarthritis of the knee. exclusion criteria: * - inflammatory arthritis. * patients who are not able to participate in the fast-track surgery program. * patients with a contralateral knee arthroplasty. * patients who are unable to provide informed consent. * disseminated malignant disease (cancer) and treatment with radiation or chemotherapy. * serious systemic disease (e.g.. hemiparesis and severe parkinsonism) * on-going case involving work injury of the knee. * female patients with a wish of becoming pregnant in the study period.
study to assess changes in the immune profile in adults with early rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to examine changes in immune cells and proteins in response to treatment with two approved therapies for rheumatoid arthritis (ra), abatacept versus adalimumab, both given in combination with methotrexate.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * symptoms of ra for no more than 12 months prior to enrollment * meet american college of rheumatology/european league against rheumatism (acr/eular) 2010 criteria for classification of ra * treated with methotrexate (mtx) for at least 12 weeks prior to randomization with a stable oral dose for at least 4 weeks, subjects must randomize on the maximum tolerated dose of oral methotrexate (minimum of 15 mg and maximum of 25 mg per week), dose of mtx \< 15 mg/week but ≥ 7.5 mg/week is permitted if subjects are intolerant to higher doses * at least 3 tender \& 3 swollen joints * anti-cyclic citrullinated peptide (ccp) \> 3x the upper limit of normal and positive rheumatoid factor exclusion criteria: * history of other autoimmune diseases (eg, psoriasis, systemic lupus, erythematosus, etc) * prior use of non-biologic therapy other than methotrexate * prior use of biologic and targeted synthetic disease-modifying anti-rheumatic drugs (dmard) therapy * subjects with chronic or recent acute serious infection other protocol defined inclusion/exclusion criteria could apply
a modified rehabilitation intervention for working persons with arthritis

Conditions: Arthritis

Summary: the purpose of this study is to explore the effects of a brief vocational rehabilitation intervention on individuals with arthritis who are concerned about their ability to remain employed.


Eligibility criteria:
inclusion criteria: * live or work in eastern massachusetts * age 25-63 years * risk of work loss due to arthritis * arthritis * chronic back pain * currently employed exclusion criteria: * unemployed * no arthritis

Keywords: supportive employment vocational rehabilitation
proton therapy for hodgkin lymphoma

Conditions: Hodgkin Lymphoma

Summary: the purpose of this study is to reduce the risk of radiation related side effects and complications by treating with radiation (protons or photons) that exposes less of normal organs to low dose radiation.

3 treatment plans will be created to deliver between a total of 21-39.6 gray (gy)/centigray equivalents (cge) to the planning target volume (ptv). 1. proton plan 2. conventional plan 3. intensity modulated radiotherapy (imrt) plan the patient will then receive the radiation modality with the lowest percentage of the body receiving 4 gy (v4gy/cge)

Eligibility criteria:
inclusion criteria: * confirmed "classic" hodgkin lymphoma. * completed chemotherapy. exclusion criteria: * prior radiotherapy. * prior or concurrent cancer other than non-melanomatous skin cancer.

Keywords: hodgkin lymphoma, proton radiation
neuro-rehabilitation training effects on motion and quality of life after acute stroke and post stroke

Conditions: Stroke

Summary: high intensity motion improves motor functions and quality of life in a neurologist. the investigators want to improve the clinical condition and quality of life of post-stroke participants with a special sensory motor and visual motor agility therapy.

high intensity motion improves engine function and quality of life in a neurologist. with special sensory motor and visual motility, investigaters want to improve the clinical condition and quality of life of stroke participants. the investigaters randomly select participants who only perform the rehabilitation treatment have performed. the other group that will receive the study's control group will receive the traditional rehabilitation physiotherapy treatment. the investigaters assess the condition and quality of life of the patients. (eq5-d, barthel index, mrs test) the ivestigaters examine the functional movement and equilibrium variables of patients. (6mwt, berg balance test, postgraduation) after that, participants are undergoing a 4-week intensive rehabilitation treatment. all participants are in post stroke. primary hypothesis will be changes in life-quality tests (eq5-d, barthel index, mrs test). functional tests show progress 6mwt, berg balance test and postural control testing with posturography. the results are compared and evaluated among the groups. the expected hypothesis is that visual and acoustic stimulation produces a better physical state at higher intensity.

Eligibility criteria:
inclusion criteria: * post stroke * 6mwt : 120\> * minimum after stroke 2 weeks exclusion criteria: * sever heart problem * sever demeanor * alcoholism * drug problems

Keywords: balance movement exergaming posture quality of life gait
optimising a digital diagnostic pathway for heart failure in the community

Conditions: Heart Failure

Summary: this is a prospective, observational study. the primary aim is to assess the diagnostic accuracy of artificial intelligence (ai) analysis of point of care (poc) handheld transthoracic echocardiogram images (poc handheld echocardiogram) compared to the current gold-standard of transthoracic echocardiogram images acquired and analysed by a british society of echocardiography (bse) accredited operator, using a standard echocardiogram machine (standard tte), for the diagnosis of heart failure with reduced ejection fraction (hfref), in patients referred from the community for investigation of suspected new heart failure (hf).

1. demonstrate that in comparison to using the current gold standard of bse accredited operator echocardiography within a hfdp, using ai enhanced analysis of poc handheld echocardiography is accurate and safe. this has the potential to improve access to timelier echocardiography in order to achieve earlier hf diagnosis and treatment, which is known to delay/prevent progression to hf hospitalisation. it will also provide useful information regarding the future feasibility of using ai enhanced analysis of poc handheld echocardiography in the community, for investigation of people with suspected new hf. 2. facilitate the digitisation of an nhs heart failure diagnostic service in order to standardise and improve the quality of data collection and clinical care provided within the service.

Eligibility criteria:
inclusion criteria: * adult individuals referred from the community who are awaiting hf diagnostic investigations, including echocardiography, to investigate for a suspected new diagnosis of hf exclusion criteria: 1. individuals less than 18 years of age 2. individuals who have had an interim echocardiogram for another clinical reason, whilst on the outpatient echocardiogram waiting list for investigation of hf 3. individuals with a previous icd-10 diagnosis of hf in any coding position 4. inability of the participant, in the opinion of the investigators, to understand and/or comply with study procedures, or any conditions that, in the opinion of the investigators, may render the participant unable to understand, attend and/or undergo study visit investigations 5. inability to read and understand the pis (provided in english only), and understand the research team

Keywords: echocardiogram ntprobnp digital diagnosis
comparison of clinical efficacy of a herbal and a non-herbal mouthwash on dentinal hypersensitivity

Conditions: Dentinal Hypersensitivity

Summary: aim of this study was to assess and compare the efficacy of a commercially available novel herbal mouthwash containing potassium nitrate on dentinal hypersensitivity (dh) compared to a placebo and non herbal potassium nitrate over a period of 12 weeks.

a total of 120 subjects were divided into 3 groups randomly. group 1 was given the placebo mouthwash, group 2 was given the herbal mouthwash ( hiora k, which contains potassium nitrate derived from suryakshara plant) and group 3 was given the non herbal mouthwash (containing non herbal potassium nitrate). sensitivity scores (vas score) were recorded at baseline, 3 weeks, 6 weeks and 12 weeks.

Eligibility criteria:
inclusion criteria: * subjects with a history of dh caused by gingival recession or cervical erosion were selected at baseline. subjects with a minimum 20 natural permanent teeth and at least two teeth with a vas score of ≥4 were included in the study. exclusion criteria: * of teeth with caries, defective restorations, chipped teeth and deep periodontal pockets (probing depth \>4 mm). also, the subjects who had undergone periodontal surgery within the previous six months, and those with orthodontic appliances or bridge work that would interfere with evaluation were excluded. subjects with the presence of occlusal overload or occlusal adjustment recently made in the tooth to be studied were also excluded. subjects who had undertaken treatment with any product that could influence the dh of the patient in the 30 days prior to baseline were excluded. also, the subjects with allergy to the ingredients used in the study or exhibiting any gross oral pathology, eating disorders, chronic disease, pregnancy and lactation, acute myocardial infarction within the past six months, uncontrolled metabolic disease, major psychiatric disorder, heavy smoking or alcohol abuse, any systemic disease or any disease requiring repeated or regular analgesia, anti-inflammatory drugs, or antihistamines were excluded from the study.

Keywords: dentinal hypersensitivity gingival recession visual analogue score
reinforcement learning for warfarin dosing

Conditions: Clotting Disorder

Summary: this is a clinical study designed to test the hypothesis that a computer model for dosing warfarin is superior to current clinical practice. subjects will be randomized to two groups based on how warfarin dose is determined and followed for 6 months. the primary outcome is the percent of the time that the inr is maintained in the effective range.

this will be a single-center, open-label, randomized prospective study. primary outcome will be percent of time within a specific inr range. subjects will be randomized to to control and treatment groups and stratified 1:1 based on sex. the control group will have warfarin doses adjusted by experts in the treatment of patients with warfarin. the treatment group will have warfarin doses determined using a clinical support tool based on reinforcement learning. based on simulations of the experimental design with an expectation that the percent of inr values within the target range increase by 20%, 70 subjects per group are required for statistical significance. based on an attrition rate of 15%, the investigators will enroll 80 subjects per group. statistical analysis will compare the percent of patients within the target inr range between groups as the primary outcome with number of adverse events between groups as the safetly outcome.

Eligibility criteria:
inclusion criteria: * receiving anticoagulation treatment with warfarin. exclusion criteria: * pregnancy. * history of hemorrhagic cerebrovascular incident. * acquired or inherited hemophilia. * thrombocytopenia (\<100,000 platelets per mm3) on 2 occasions separated by 2 days. * anemia with hemoglobin concentration \< 10 g/dl. * active cancer excluding non-melanoma skin cancers. * active liver disease as documented by prolonged baseline inr ≥ 1.6. * uncontrolled hypertension with 2 readings \>180/110. * recent (\< 2 weeks) neurosurgical procedure. * enrollment in hospice program for any diagnosis.

Keywords: warfarin
double-blind pilot study on the effect of anionic exposome enrichment (biow) on recovery and sleep quality in postoperative patients

Conditions: Inflammatory Response After Surgery; Postoperative Recovery

Summary: airborne nanoparticle exposure is increasingly recognized as a significant contributor to oxidative stress, mitochondrial dysfunction, and low-grade systemic inflammation-factors that impair postoperative recovery. the world health organization and european initiatives such as the human exposome project have highlighted the clinical importance of the exposome, defined as the totality of environmental exposures influencing health throughout life. eox is a ce-certified air regeneration system designed to modify the indoor exposome through a dual mechanism: advanced filtration and controlled emission of bioavailable anions using cold atmospheric plasma (cap). its multistage filter removes particulate matter, pathogens, and volatile organic compounds, while the anionic plasma phase modulates cellular oxidative balance and metabolic function. experimental and clinical data indicate that exposure to eox improves mitochondrial efficiency, increases atp production, and reduces oxidative protein damage. eox has also been shown to influence molecular pathways involved in stress adaptation and repair, such as the hif-1α-vegf-epo axis and protein synthesis signaling (e.g., mtor-p70s6k). these mechanisms may collectively enhance tissue recovery, vascularization, and metabolic resilience in the postoperative setting. the present study investigates the effects of eox in hospitalized postoperative patients, evaluating both subjective (sleep quality, well-being) and objective (vital signs, metabolomics, microbiota composition) endpoints. the central hypothesis is that eox induces a beneficial hormetic response-an adaptive reaction to mild environmental stressors-reflected by improved clinical recovery and biomarker modulation (e.g., succinate reduction, increased atpase activity). the goal is to assess whether eox can serve as an effective environmental intervention to support physiological healing and improve the quality of inpatient recovery.


Eligibility criteria:
inclusion criteria: * adults aged ≥18 years, regardless of sex. * undergoing elective general surgery, preferably hepatobiliary procedures. * hospitalized for at least 4 days postoperatively in unit 69 (hufjd). * able to provide written informed consent. * considered to have medium or high risk of oxidative stress or mitochondrial dysfunction. exclusion criteria: * surgery within the previous 6 months, either outpatient or inpatient. * diagnosed psychiatric or neurological disorders, including epilepsy. * active progressive cancer or chronic inflammatory disease. * cognitive impairment or inability to comply with study procedures. * bmi ≥30 kg/m² (obesity class i or higher).

Keywords: exposome bioavailable anions postoperative recovery mitochondrial function oxidative stress surgical inflammation
product feasibility of a new silicone hydrogel contact lens

Conditions: Myopia

Summary: the objective of this study is to determine the clinical feasibility and to evaluate the product performance of investigational contact lens.


Eligibility criteria:
inclusion criteria: * subjects must have clear central corneas and be free of any anterior segment disorders. * subjects must be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand. * subjects must be myopic and require lens correction exclusion criteria: * subjects with any systemic disease affecting ocular health. * subjects using any systemic or topical medications that will, in the investigator's opinion, affect ocular physiology or lens performance. * subjects with an active ocular disease or are using any ocular medication. * subjects with any "present" finding during the slit lamp examination that, in the investigator's judgment, interferes with contact lens wear.